Access assembly insertion device

ABSTRACT

An improved access assembly is provided. The access assembly includes an inflatable port and an inflation cannula operably connected to the inflatable port to provide inflation fluid to the inflatable port. The inflatable port may be tapered in a first configuration to facilitate insertion through tissue. The inflation port defines a substantially hour-glass shape when in a second configuration to create a seal within an opening in the tissue.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 61/435,421 filed on Jan. 24, 2011, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to apparatus and method for accessing abody cavity. More particularly, the present disclosure relates to aninflatable assembly for accessing a body cavity.

2. Background of Related Art

Access assemblies configured for reception through an incision into anabdominal cavity are known, as are methods of inserting the accessassemblies therethrough. Traditional access assemblies include a rigidcannula that is received through the tissue of the body wall into thebody cavity. Endoscopic, laparoscopic and other suitable instruments maythen be directed through a housing on the proximal end of the cannula toaccess the body cavity in a sealing manner.

Compressible assemblies configured for accessing a body cavity andpermitting reception of instruments therethrough in sealing manner arealso known. Such compressible assemblies are composed of silicone,thermoplastic elastomers (TPE), rubber, foam, gel and other compressiblematerials and are configured to be compressed to facilitate insertioninto an incision. Typically, such assemblies are deformed by a surgeonusing his/her fingers or with the assistance of a grasping device, i.e.,forceps. Compression of the assembly reduces the profile of theassembly, thereby facilitating reception of the assembly into theincision. Upon release of the compressive force, the compressed assemblyreturns to an uncompressed configuration. In the uncompressedconfiguration, the access assembly seals the incision into the bodycavity. The assembly may have one or more access ports for receivinginstruments therethrough and may optionally be configured for connectionwith a source of insufflation gas.

Excessive handling of the compressible access assemblies duringplacement of the assembly through an incision may compromise orotherwise negatively effect the integrity of the assembly. For example,any coating on the assembly may be rubbed off during handling, orexcessive force, oversized/undersized fingers and/or sharp graspinginstruments may tear the material comprising the assembly.

Therefore, it would be beneficial to have an access assembly configuredto be inserted through tissue without excessive handling and/or withoutthe need for an insertion device.

SUMMARY

Accordingly, an improved access assembly is provided. The accessassembly includes an inflatable port and an inflation cannula operablyconnected to the inflatable port to provide inflation fluid to theinflatable port. The inflatable port may be tapered in a firstconfiguration to facilitate insertion through tissue. The inflation portdefines a substantially hour-glass shape when in a second configurationto create a seal within an opening in the tissue.

The inflatable port may include an upper rim configured to be receivedexternal of the tissue and a lower rim configured to be received withina body cavity. In one embodiment, the inflation cannula includes asharpened distal tip. The access assembly may further include a sleeveto maintain the inflatable port in the tapered configuration. A proximalend of the inflation cannula may be configured for operable connectionwith a source of inflation fluid. The inflatable port may be one ofmolded, extruded and sewn. In one embodiment, the inflatable port istwisted about the inflation cannula when in the first configuration.

Also provided is a method of accessing a body cavity. The methodincludes the step of providing an access assembly including aninflatable port and a inflation cannula, wherein the inflatable portinclude a tapered configuration to facilitate reception through tissueand an hour-glass configuration to maintain the assembly within tissue,inserting the tapered access assembly through tissue, inflating theinflatable access assembly, and performing a procedure through theaccess assembly.

The method may further include the steps of deflating the inflatableport and removing the port from the tissue. Additionally, the method mayinclude the step of creating an incision in the tissue and connectingthe inflation cannula with a source of inflation fluid. The inflationcannula may include a piercing tip.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiment(s) given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of an embodiment of an access assemblyaccording to an aspect of the present disclosure, in a first or taperedconfiguration;

FIG. 2 is a partial cross-sectional top view of the access assembly ofFIG. 1, taken along line 1-1;

FIG. 3 is a perspective view of the access assembly of FIGS. 1 and 2, ina second or deflated configuration;

FIG. 4 is a perspective view of the access assembly of FIGS. 1-3, in athird or inflated configuration;

FIG. 5 is a cross-section side view of the access assembly of FIGS. 1-4,in the third or inflated configurations; and

FIGS. 6-10 illustrate sequential steps for providing access to a bodycavity using the access assembly of FIGS. 1-5.

DETAILED DESCRIPTION

Embodiments of the presently disclosed apparatus will now be describedin detail with reference to the drawings, in which like referencenumerals designate identical or corresponding elements in each of theseveral views. As used herein, the term “distal” refers to that portionof the tool, or component thereof which is further from the user whilethe term “proximal” refers to that portion of the tool or componentthereof which is closer to the user. While the use of the accessassembly is often described herein as engaging an incision, it should berecognized that this is merely exemplary and is not intended to limitthe use of the assembly in any way, but rather it should be recognizedthat the present invention is intended to be useable in all instances insituations in which the access assembly engages an incision, a naturallyoccurring orifice, or any other suitable opening.

Referring initially to FIGS. 1-5, an assembly for access a body cavityis shown generally as access assembly 100. In a first or taperedconfiguration (FIGS. 1 and 2), access assembly 100 is configured to beinserted through an incision or other opening in tissue withoutexcessive handling or manipulation of assembly 100 and without aseparate insertion device. Alternatively, and as will be discussed infurther detail below, access assembly 100 may include a sharpened orbladed tip configured for creating the opening in the tissue forreception of access assembly 100 therethrough. In a second or deflatedconfiguration (FIG. 3), access assembly 100 is configured to bewithdrawn from an opening following completion of a surgical procedure.In a third or inflated configuration (FIG. 4), access assembly 100 isconfigured to selectively seal an opening through tissue into a bodycavity. In the third configuration, access assembly 100 is furtherconfigured to receive one or more instruments therethrough in a sealingmanner. 100201 With reference still to FIGS. 1-5, access assembly 100includes an inflatable port 110 and an inflation cannula 130. Inflatableport 110 is constructed of plastic, polymer, fabric or other suitablematerial. Inflatable port 110 may be molded, extruded, sewn or formed inany other suitable manner. Inflation cannula 130 is formed of plastic,polymer, metal or any other suitable material. In one embodiment, and asshown, inflation cannula 130 is securely affixed to inflation port 110by adhesive, bonding, welding or other suitable means. In an alternativeembodiment, inflation cannula 130 may be configured for selectiveengagement with inflatable port 110. In this manner, inflation cannula130 does not interfere with manipulation of instruments inserted throughinflatable port 110.

Inflation cannula 130 includes one or more openings 132 formed along alength thereof in communication with a cavity 111 (FIG. 5) withininflatable port 110. A proximal end 130 a of inflation cannula 130 isconfigured for operable connection to a source of inflation fluid 50(FIG. 6). Proximal end 130 a of cannula 130 may extend beyond a proximalend 116 of inflatable port 110, as shown, and may include a connectionassembly 134 configured to operably connect with a inflation tube 52(FIG. 6). Alternatively, proximal end 130 a of cannula 130 may berecessed within inflatable port 110. In this manner, proximal end 130 aof cannula 130 will not obstruct manipulation of an instrument insertedthrough port 110. In another embodiment, proximal end 130 a of cannula130 is integrally formed with inflation tube 52. As will be discussed infurther detail below, a distal end 130 b of inflation cannula 130 may bepointed, sharpened or otherwise configured to facilitate insertion ofaccess assembly 100 through tissue.

With particular reference now to FIGS. 1 and 2, in the first or taperedconfiguration, access assembly 100 forms a substantially tapered memberconfigured to be inserted through an opening formed in tissue. Accessassembly 100 may be provided to a surgeon in the first configuration orinstead are provided in the second configuration, and thus requireforming into the tapered configuration prior to insertion throughtissue. Inflation cannula 130 extends at least partially along thelength of inflatable port 110 and may include a tapered configuration tofacilitate the shaping of inflatable port 110 thereabout and/or tofacilitate insertion of access assembly 100. It is envisioned thatinflation cannula 130 may extend beyond a distal end of inflation port110 to further facilitate insertion of access assembly 100 throughtissue.

With reference still to FIGS. 1 and 2, in one embodiment, and as shown,inflatable port 110 is twisted about inflation cannula 130 to achievethe tapered configuration. Inflatable port 110 may be maintained in thetapered configuration using a temporary adhesive, a dissolvable coating,a tear-away sleeve 113 (FIG. 2, shown in phantom) or any other suitablemeans. In an alternate embodiment, a shrink-wrap sleeve or tube may beused to achieve the tapered configuration of access assembly 100. Aswill be described in further detail below, either upon receipt within anopening formed in tissue or upon the start of inflation of inflatableport 110, the adhesive, coating, sleeve 113 or other materialmaintaining inflatable port 110 in the tapered configuration dissolves,tears or otherwise releases inflatable port 110 from the taperedconfiguration, thereby permitting inflation of inflatable port 110.

With reference now to FIG. 3, access assembly 100 is shown in a secondor deflated configuration. During use, access assembly 100 is in thesecond or deflated configuration prior to inflation of inflatable port110 and upon completion of a procedure therethrough. In the second ordeflated configuration, inflatable port 110 defines a member having asubstantially similar shape to that of the inflated inflatable port 110,as described below. In the second or deflated configuration, accessassembly 110 may be adjusted within an opening in tissue and/or may beremoved therefrom.

With particular reference now to FIG. 4, access assembly 100 is shown inthe third or inflated configuration. In the third or inflatedconfiguration, inflatable port 110 creates a seal within an opening toprevent the escape of insufflation gas therethough. Inflatable port 110may be inflated with any suitable fluid, including an insufflation gasor water. Inflatable port 110 defines a substantially hourglass shapewhen viewed from the side. Inflatable port 110 includes a centralportion 112 having an upper rim 114 located at a proximal end 116 ofcentral portion 112 and a lower rim 118 located at a distal end 120 ofcentral portion 112. Upper rim 114 and lower rim 118 aid in minimizingmovement of access port 110 longitudinally through an opening. Centralportion 112 is of a length sufficient that upper rim 114 is maintainedexternal the body while lower rim 118 is received within the abdominalcavity.

With specific reference now to FIG. 5, a plurality of lumen 122 extendthrough port 110 along a longitudinal axis and are configured to receivesurgical instruments therethrough in a sealing manner. Although shownincluding two lumen 122, it is envisioned that access assembly 100 mayinclude one or more lumen 122. Although shown including a centrallylocated inflation cannula 130 and radially spaced lumen 122, it isenvisioned that the arrangement of inflation cannula 130 and the one ormore lumen 122 may be modified to better suit an application orprocedure. Lumen 122 may be configured to directly seal one or moreinstruments inserted therethrough. Alternatively, each of lumen 122 mayinclude one or more valve members (not shown) for receiving aninstrument therethrough in a sealing manner. Additionally, the one ormore valve members may seal lumen 122 in the absence of an instrumentreceived therethrough. In yet another embodiment, lumen 122 areconfigured to receive cannula assemblies (not shown) therein. Each ofthe cannula assemblies may include a valve member for receiving aninstrument in a sealing manner.

With reference now to FIGS. 6-10, the use of access assembly 100 will bedescribed. Whether inflatable port 110 is provided to a surgeon in thetapered configuration of FIGS. 1 and 2, or in the non-taperedconfiguration of FIGS. 3 and 4, and thereby requires furthermanipulation by a surgeon to form the tapered configuration, accessassembly 100 is initially received through tissue “T” with inflatableport 110 in the tapered configuration to facilitate insertion thereof.As discussed above, access assembly 100 may be inserted through anincision “I” in tissue “T” that has been created by an incision.Alternatively, inflation cannula 130 of access assembly 100 may includea piercing or cutting tip to create incision “I” as access assembly 100engages tissue “T”. In yet another procedure, access assembly 100 isinserted through a natural opening, i.e., anus or vagina. As discussedabove, access assembly 100 may be operably connected to a source ofinsuflation gas 50 via tube 52 prior to, during, or upon insertion ofaccess assembly 100 within incision “I”.

Once received through tissue “T” (FIG. 7), either upon receipt withintissue “T” or upon the start of inflation of inflatable port 110, theadhesive, coating, sleeve or other material maintaining inflatable port110 in the tapered configuration dissolves, tears or otherwise releasesinflatable port 110 from the tapered configuration, thereby permittinginflation of inflatable port 110.

Turning now to FIGS. 8 and 9, inflatable port 110 is inflated withintissue “T” to seal incision “I”. Inflatable port 110 operates as aconventional access assembly, capable of receiving one or moreinstruments or devices “D” through lumen 122. Tube 52 may bedisconnected from proximal end 130 a of cannula 130 to preventinterference therewith as instruments “D” are manipulated through accessassembly 100.

With reference now to FIG. 10, once a procedure is completed, inflatableport 110 is deflated either by opening a valve (not shown) or piercinginflatable port 110 to return inflatable port 110 to the deflatedconfiguration to permit removal from within incision “I”. In thedeflated configuration, inflatable port 110 may be easily removed fromtissue “T”. Incision “I” may then be closed in a conventional manner.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to those preciseembodiments, and that various other changes and modifications may beeffected therein by one skilled in the art without departing from thescope or spirit of the disclosure.

The invention claimed is:
 1. A method of accessing a body cavitycomprising: providing an access assembly including an inflatable portand a rigid inflation cannula fixedly received within the inflatableport, wherein the inflatable port is transitionable between a taperedconfiguration to facilitate reception of the access assembly throughtissue and an hour-glass configuration to maintain the access assemblywithin tissue; inserting the access assembly through tissue when theinflatable port is in the tapered configuration; securing the accessassembly within the tissue by inflating the inflatable port to thehour-glass configuration; and performing a procedure through theinflatable port.
 2. The method of claim 1, further including deflatingthe inflatable port and removing the inflatable port from the tissue. 3.The method of claim 1, further including creating an incision in thetissue.
 4. The method of claim 1, wherein the rigid inflation cannulaincludes a piercing tip.
 5. The method of claim 1, further includingconnecting the rigid inflation cannula with a source of inflation fluid.6. The method of claim 5, further including disconnecting the rigidinflation cannula from the source of inflation fluid once the inflatableport is sufficiently inflated.
 7. The method of claim 1, furtherincluding transitioning the inflatable port to the taperedconfiguration.
 8. The method of claim 7, wherein transitioning theinflatable port to the taper configuration includes wrapping theinflatable port about the rigid inflation cannula.
 9. The method ofclaim 4, wherein inserting the access assembly through tissue includespiercing the tissue with the piercing tip of the rigid inflationcannula.
 10. The method of claim 1, wherein the inflatable port includesa plurality of lumens for receiving instruments in a sealing manner,wherein performing a procedure through the inflatable port includesreceiving instruments through the plurality of lumens.
 11. The method ofclaim 1, wherein the rigid inflation cannula extends through theinflation port.
 12. A method of accessing a body cavity comprising:providing an access assembly including an inflation cannula having asharpened tip and an inflatable port securely affixed to the inflationcannula, wherein the inflatable port is transitionable between adeflated configuration to facilitate reception of the access assemblythrough tissue and an inflated configuration to maintain the accessassembly within tissue; inserting the access assembly through tissuewhen the inflatable port is in the deflated configuration by piercingthe tissue with the sharpened tip of the inflation cannula; inflatingthe inflatable port; and performing a procedure through the inflatableport.
 13. The method claim 12, further including wrapping the inflatableport around the inflation cannula when the inflatable port is in thedeflated configuration to facilitate inserting the access assemblythrough tissue.
 14. The method of claim 12, wherein the sharpened tip ofthe inflation cannula extends beyond the inflatable port when theinflatable port is in the deflated configuration.